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Roche won another reprieve in its fight against Accutane safety claims. The...drugmaker persuaded a New Jersey appeals court to overturn an $18 million jury verdict in favor of two Accutane (isotretinoin) plaintiffs...Appellate Division ruled...that the trial court judge "seriously erred" in allowing some revelations in court while restricting others. The judge’s mistakes were weighty enough to warrant a new trial...It’s the latest in a series of victories on appeal for Roche...The lawsuits are among 3,000 assigned to multicounty litigation in New Jersey. The plaintiffs allege that Roche’s acne drug, pulled from the market in 2009, triggered their inflammatory bowel disease...Accutane once was a blockbuster med for Roche and a staple therapy for acne sufferers. Roche pulled Accutane for "business reasons"...long after the drug went off patent and generics hit the market. The company already was facing hundreds of liability lawsuits at the time

U.S. antitrust officials are poised to file lawsuits to block Anthem Inc.’s takeover of rival health-insurer Cigna Corp. and Aetna Inc.’s deal to buy Humana Inc...Justice Department officials, who are responsible for protecting competition, are concerned that the deals, which would transform the health-insurance industry by turning its five biggest companies into three, would harm customers, according to several people familiar with the situation. While the companies may offer to sell assets to gain approval for the deals, that’s unlikely to sway antitrust officials...The final decision on whether to sue to block the deals could come this week or next, another of the people said. The companies could settle a lawsuit before or after one is filed...

Attorney General Adam Laxalt is suing an insurance company alleging breach of contract and bad faith for failing to defend Nevada and pay its $400,000 settlement with the city of San Francisco over allegations of patient dumping...The lawsuit filed...against The Insurance Company of the State of Pennsylvania...seeks unspecified compensatory and punitive damages, along with costs and attorney’s fees...San Francisco sued Nevada in 2013 following an investigation by the Sacramento Bee into patients at Rawson-Neal Psychiatric Hospital in Las Vegas being provided bus tickets. The lawsuit claimed about 500 patients arrived in California and about two dozen were bused to San Francisco, many needing medical treatment and shelter. The city sought reimbursement for their care…Nevada settled the lawsuit in 2015...the action against the insurance company, alleges the carrier failed to investigate San Francisco’s claims against Nevada and invoked "inapplicable coverage exclusions" to escape its duty to defend and indemnify Nevada from San Francisco’s lawsuit...

Anthem and its pharmacy manager Express Scripts overcharged patients with job-based insurance for prescription drugs, alleges a lawsuit that seeks class action status for what could be tens of thousands of Americans...the latest wrinkle in a battle that has already pitted the major national insurer and its pharmacy benefit manager against each other in dueling legal actions...The case alleges that insured workers paid too much because Express Scripts charged "above competitive pricing levels" and Anthem, in effect, allowed those higher prices...Those actions...violate the firms’ responsibilities under a 1974 federal benefits law called the Employee Retirement Income Security Act...This action seeks to recover losses suffered by the plaintiffs…who overpaid and continue to overpay for the portions of the costs of prescription drugs…they are responsible for paying as plan participants," says the lawsuit, filed as Burnett v. Express Scripts and Anthem.

A Johnson & Johnson subsidiary has agreed to pay $18 million to resolve charges of causing health care providers to submit false claims to Medicare and other federal health care programs, which then paid for a device that was illegally marketed...The settlement...comes...two days after a pair of former executives at...Acclarent, were found guilty of several misdemeanor charges of distributing a misbranded and adulterated device. A federal court...found the executives marketed the Stratus device for a use that was not approved by the Food and Drug Administration... Acclarent won FDA approval to market its Stratus device (Relieva Stratus Microflow Spacer) to be used only with saline to maintain sinus openings following surgery. But the feds alleged the company intended to market Stratus as a drug-delivery device for prescription corticosteroids and maintained the device was specifically designed and engineered for this use...The episode stems from a whistleblower lawsuit that was filed...by Melayna Lokosky, a former Acclarent sales rep...Her lawsuit described the steps that Acclarent had taken to promote the device and allegedly deceive physicians about its efficacy. She is expected to receive about $3.5 million from the settlement.

A long-running court case filed in India by Roche seeking to prevent the use of label language by...Biocon and Mylan from claiming similarity to its aging breast cancer med Herceptin (trastuzumab) has turned tense--with both sides now seeking contempt-of-court charges...In the case of Roche...Biocon "violated a previous court order" temporarily barring any claims to similarity by using such language in a presentation at an international scientific conference on clinical trials with trastuzumab...At the same time, Biocon accused Roche of "disparaging statements" about the company as part of a campaign to block approval efforts for a trastuzumab biosimilar by Biocon in other countries...noting that Phase III trials are underway in the U.S. for a version of the breast cancer therapy...At the heart of the case is...that Biocon and...Mylan could not use the label biosimilar for versions of Roche's med.

Johnson & Johnson...was ordered...to pay $70 million to a male Tennessee teenager who claimed its Risperdal antipsychotic pill caused him to grow enlarged breasts. The finding by a Pennsylvania state court jury was not only the latest, but it is the biggest defeat to date in what has become another sprawling litigation over the drug....jury found that J&J failed to properly warn Risperdal could cause gynecomastia...also determined that the company "intentionally falsified, destroyed, or concealed records" that Risperdal could cause boys to develop breasts...J&J has a bad track record when it comes to marketing Risperdal...In 2013, the company paid more than $2.2 billion to resolve criminal and civil charges of illegally promoting the drug for unapproved uses...J&J reputation. The health care giant has portrayed itself as a trustworthy corporate brand, but has endured several episodes that have sullied its well-honed image...

U.S. antitrust officials on Thursday moved to block an unprecedented consolidation of the national health insurance market, filing suit against Anthem Inc's proposed purchase of Cigna Corp and Aetna Inc's planned acquisition of Humana Inc...The U.S. Department of Justice said the two mergers would reduce competition, raise prices for consumers and stifle innovation if the number of large, national insurers were to fall from five to three..."We will not hesitate to intervene. We will not shy away from complex cases," U.S. Attorney General Loretta Lynch told a news conference. "We will protect the interests of the American people."

A closely watched skirmish over the cost of prescription drugs has ended in defeat for a company that sought to challenge the right of a Canadian agency to impose a price cap on a pricey medicine...Canada’s Federal Court dismissed a constitutional challenge that Alexion Pharmaceuticals filed against the Patented Medicine Prices Review Board, which...sought to keep a lid on the cost of the company’s Soliris (eculizumab) medication...The...agency had asked Alexion to lower its price and repay sales generated by the drug from 2012 through the first half of 2014..."It is far from surprising," said Richard Gold, a professor at McGill University..."Alexion may still appeal in hopes that the Supreme Court of Canada will alter the law. I think the [possibility that the court will find] the provisions unconstitutional are remote. Parliament can create and limit patent rights as it wishes, but pharmaceutical companies have been known for being obstinate in the face of logic."

A federal appeals court...that biosimilar makers must always notify their brand-name rivals six months before launching expensive biologic medicines. The decision may have a significant impact on near-term health care costs, because it will effectively delay competition for these pricey drugs...The stipulation is designed to give a brand-name company time to determine what, if any, patent challenges can be pursued before a biosimilar is launched. In a closely watched case last year, the federal appeals court already ruled that biosimilar companies must wait until they actually receive Food and Drug Administration approval before giving 180-day notice to a brand-name rival...today’s decision will answer an important policy question and serve as a broader benchmark for the entire pharmaceutical industry going forward...A great deal is at stake for patients and payers because biosimilars are estimated to save as much as $44 billion in US health care costs over the next decade. Many insurers and analysts forecast that biosimilars will cost 10 percent to 30 percent less than brand-name biologics, although the number is a moving target, given that companies raise biologics prices to anticipate competition...